FDA cGMP Full Quality System – HCCT Master Package
Multilingual support available in English, Simplified Chinese.
2026 Version Update: – 69 Professional SOPs – 13 Modules with Manuals – 300+ Document for Plugins – cGMP & cGTP Compliance – Monitor by real Professionals
The HCCT Master Package combines comprehensive FDA-aligned quality documentation with an integrated Quality Assurance management software system, creating a complete turnkey solution for HCTP, cell therapy, and exosome manufacturing operations.
Package Components:
69 Professional SOP Documents organized in 13 compliance modules
Flask-based QA Management System with 12 integrated modules
Regulatory Coverage: 21 CFR 210/211 (Drug cGMP), 21 CFR 1271 (HCTP cGTP), 21 CFR Part 11 (Electronic Records), ICH Q9/Q10
Documentation + QA Software System – Flask-based web application (runs locally at http://localhost:5000) – SQLite database (17 tables, auto-created on startup)
12 Integrated Quality Management Modules
a. Dashboard — Real-time KPIs, charts, activity feed b. Document Control — Lifecycle management with electronic approval (21 CFR Part 11) c. Deviation Management — Classification, investigation, root cause, product disposition d. CAPA Management — Corrective/preventive actions with effectiveness verification e. Change Control — Risk-based classification (Major/Minor/Emergency/Like-for-Like) f. Batch Release & QC — 10-test panel, Certificate of Analysis, electronic signature release g. Supplier Management — Qualification, performance scoring, audit frequency h. Training & Personnel — Records, competency matrix, qualification tracking i. Internal Audit — Audit planning, findings management, CAPA linkage j. Complaints & Pharmacovigilance — FDA MedWatch assessment, adverse event reporting k. Annual Product Review (APR) — Aggregated quality metrics by year l. Audit Trail — Append-only log of all system actions (21 CFR Part 11 compliant)
Software Features:
• Role-based access control (Admin, QA Manager, QA Specialist, Production, QC, Readonly) • Electronic signatures with password verification • Bilingual interface (English/Simplified Chinese toggle) • Chart.js visualizations (deviation trends, CAPA status, batch disposition) • Export capability for APR data and Certificate of Analysis • No internet required after initial setup • Single-file SQLite database for easy backup
Technical Specifications:
• Backend: Python Flask (single app.py file, 50 API routes) • Database: SQLite (qa_system.db) • Frontend: HTML/CSS/JS with Chart.js • Deployment: Local service (localhost:5000) • Prerequisites: Python 3.8+, modern web browser
69 SOPs Across 13 Compliance Modules
Module 01: Quality Assurance & QMS (14 Documents) • Quality Manual and Pharmaceutical Quality System • GMP/GTP Requirements Mapping & Gap Analysis • Document & Record Control • Deviation, Investigation & CAPA Management • Change Control Procedure • Internal Audit & Inspection Readiness • Training, Qualification & Competency Management • Supplier Qualification & Material Release • Equipment Qualification, Calibration & Maintenance • Process Validation & Ongoing Process Verification • Data Integrity & Electronic Records Oversight • Product Quality Review / Annual Product Review (PQR/APR) • GMP Records & Reports Management
Module 02: HR & Personnel (7 Documents) • Personnel Recruitment, Qualification & Job Descriptions • GMP Induction, Training Curriculum & Annual Re-Qualification • Health, Hygiene & Medical Fitness Requirements • Gowning, Entry/Exit & Behavior in Classified Areas • Performance Evaluation, Disciplinary Actions & Retraining • Training Records, Effectiveness & Archiving • Personnel Health, Hygiene & Occupational Safety Module 03: Materials Management (5 Documents) • Material Receipt, Quarantine, Sampling & Release • Storage Conditions, Inventory & Stock Rotation (FEFO/FIFO) • Handling of Rejected, Returned & Recalled Materials • Qualification & Lifecycle Management of Supplies, Reagents & Critical Materials • Qualification, Approval & Oversight of GMP/GTP Contractors & Service Providers
Module 04: Production, HCTP Recovery & Packaging (11 Documents) • HCTP Recovery — Tissue/Cell Procurement, Labeling & Transport (361/351 HCTP) • HCTP Processing — Aseptic Handling, Hold Times & In-Process Controls • Batch Manufacturing & Packaging Record Management • Line Clearance & Status Labeling • Sampling, In-Process Controls & Yield Reconciliation • Packaging & Labeling Control • Reworking, Reprocessing & Repackaging • Batch Record Review & Production Documentation • Intermediate and Bulk Hold Time Management • MSC Exosome Product Control Strategy • HCTP Process Change Control
Module 05: Equipment (2 Documents) • Equipment Cleaning, Setup & Line Changeover • Cleaning, Use Log & Cleaning Validation
Module 06: Facilities (2 Documents) • Cleaning & Sanitation of Production and Storage Areas • Environmental Monitoring & Room Classification
Module 07: Utilities (2 Documents) • Water System Operation, Monitoring & Sanitization • HVAC Operation, Filter Management & Alarm Handling
Format – More than 300+ Sub-Documents Structure for reporting – All files in .docx format for easy editing – Structured headings for quick import into the QA Management System
